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-- UCSD Human Research Protections Program Sign in to HRPP Home About HRPP Checklists Contact Us e-IRB Services Fact Sheets FAQs Forms How To IRB Meeting Dates News Public Notices References SOPPs Topics Training Clinical Trials Directory Human Stem Cells School of Medicine UCSD Home Page UC San Diego, HRPP Home page Home News | How To | Forms | Dates | Topics | Training | e-IRB Services news January 6, 2020 Federally Supported Multisite Projects - sIRB Principal Investigators that have started new federally supported multisite projects since January 21, 2019 or are planning new proposals for such projects should especially be aware of the new requirement regarding single IRB (sIRB) review. More information about this requirement can be found here . For additional assistance, please contact the HRPP Office at irbrely@ucsd.edu . June 21, 2019 Updated FWA Statement Letter HRPP is making available an updated FWA statement letter. In addition to updating information, the letter now covers both UCSD and RCHSD and also addresses several common sponsor requests. This new content is intended to help UCSD and RCHSD PIs and Study Teams negotiate with sponsors about the standard HIPAA authorization for research or the standard consent language about treatment and compensation for injuries. To access the new letter, please see the About HRPP web page or click here . January 19, 2019 Revised Common Rule On January 21, 2019, a number of changes to the Federal Policy for the Protection of Human Subjects (aka the Common Rule) are scheduled to take effect. At this time, the UCSD IRBs and HRPP will only apply these changes to federally supported research that will receive initial IRB approval or initial certification of exemptions on or after January 21, 2019. Additional information for these changes can be found here and specifically for changes associated with the consent process, see here. May 9, 2018 New and Updated Fact Sheets A new Fact Sheet has been created titled, Expanded Access - Investigational Device . The updated Fact Sheet is titled, Investigator Initiated Clinical Trials/IND Applications . The new and the updated Fact Sheet provide updated information regarding expanded access investigational treatment including single patient treatment in both non-emergency and emergency situations. The Fact Sheets also provide links to sample treatment consent/permission/assent documents. The new and updated Fact Sheets can also be found on the Fact Sheets page . March 19, 2018 (Updated May 4, 2018) HRPP Process Improvements The HRPP has made modifications for protocol review to improve efficiency. Please note there are "Rapid-Cycle Review" procedures available for Phase 2b, 3, and 4 industry-sponsored clinical trials. Also, non-federally funded research in the Expedited Category may receive a 3-year initial review approval. Additional changes include broader eligibility for non-federally funded Exempt Category research. The Amendment Request Cover Letter form , which has been available and demonstrated to improve communication with the HRPP Office, will be required for amendment submissions in April or submissions may be considered incomplete. For more information about Rapid-Cycle Review, please see SOPP, section 3.2 , page 6. A checklist for Rapid-Cycle Review can be found here . For more information about the 3-year initial review approval, please see SOPP, section 3.10 , page 3. A checklist for 3-year initial review approval can be found here . For more information about the broader eligibility for exempt category research, please see SOPP, section 3.9 , page 2. Also, longer approval periods for studies reviewed by a convened IRB will result from making the initial approval date based upon the "last touch" date rather the date of the first Committee review. In addition, there is a new Fact Sheet for NIH Issuing Certificates of Confidentiality (see Fact Sheets webpage and here ). And there is an additional FAQ, number 16, that addresses pregnant partners/pregnant participants (please see FAQs webpage ). February 6, 2018 New Fact Sheets and Updated Biomedical Facesheets Two new Fact Sheets have been created. One Fact Sheet is regarding the NIH definition of a clinical trial. The other Fact Sheet is regarding the return of research and/or incidental findings. The Biomedical Facesheets have been updated to include an indication whether a study involves dual use research of concern (DURC) agents (more information about DURC agents can be found here ). The new Fact Sheets can be found on the Fact Sheets page. and the updated Facesheets can be found on the Biomedical Research Forms page. . December 22, 2017 (Updated January 18, 2018) Final Rule Effective Date and General Compliance Date Delay An Interim Final Rule (IFR) has been announced that delays the effective date and general compliance date for the Final Rule to July 19, 2018. Additional information about the IFR can be found here . As noted previously, the Final Rule compliance and effective date was January 19, 2018, and the Final Rule was only effective for federally supported/conducted studies initially approved on or after that date. Researchers should continue to monitor and review the HRPP website to learn of "new" information regarding the IFR and changes in policies and procedures as they become operational. October 31, 2017 Updated SOPPs The UCSD IRB/HRPP Standard Operating Policies and Procedures (SOPP), sections 1.5 and 3.12 have been updated. Section 1.5, page 1, has been updated to revise wording regarding who can be a PI on a study. Section 3.12, page 2, has been updated to reflect the use of the Amendment Request Cover Letter form and the Cover Letter for Request Change/Modification - Key Personnel Change Only form. The updated SOPPs can be obtained on the SOPPs page September 11, 2017 Updated SOPPs The UCSD IRB/HRPP Standard Operating Policies and Procedures (SOPP), sections 3.8 and 8.2 have been updated. Section 3.8 has been updated including wording regarding conflict of interest and who may serve as an IRB member (page 1). And section 8.2 has been updated to provide the definition of "Enrolled" and clarify the definition of "Generalizable Knowledge" (page 3). The updated SOPPs can be found on the SOPPs page. June 26, 2017 Updated SOPPs The UCSD IRB/HRPP Standard Operating Policies and Procedures (SOPP), sections 3.16, 3.17, 3.20, 4.2, and 5.2 have been updated. Section 3.16, page 4, has been updated to clarify wording regarding reuse and storage of data/specimens and agreements. Section 3.17, page 2 has added two additional items that cannot be part of advertisements. Section 3.20, page 3, has been updated include wording regarding data collection and participant withdrawal. Section 4.2, page 2, has been updated to include addition information regarding disapproval and page 4 has been updated to include additional information regarding review of response to a disapproved study. And section 5.2, page 1, has been updated to define suspension and termination and page 4 has been updated to include additional information regarding informing current participants and a termination or suspension. The updated SOPPs can be found on the SOPPs page . March 18, 2013 One-on-One Advising Sessions The HRPP is introducing 15-minute, One-on-One advising sessions. These sessions will be done once a month and are designed for investigators, study staff, and students conducting research involving human subjects to obtain guidance from HRPP staff. For more information, please see the Training page . HIPAA (Health Insurance Portability and Accountability Act of 1996) information for researchers Older News Items how to ... Submit a new project application Submit a response to a letter from the IRB Amend an existing project Submit information for annual (or more frequent) Continuing Review by the IRB Submit a project renewal Submit a project withdrawal or closure More forms Biomedical Research application forms Soci...